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COMPLETEDPhase 1NCT01145859

Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is...

Lead sponsor: Bayer•16 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Pediatric subjects \> 6 months and \< 18 years of age at the time of administration of study drug.
•Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE

Exclusion Criteria

•Any major or clinically relevant bleeding during prior VTE treatment
•Abnormal coagulation tests within 7 days prior to study drug administration
•Severe renal impairment
•Planned invasive procedures prior to or after 24 hours of study drug administration

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 6, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment59

Start dateNov 2010

Last updatedAug 6, 2015

Condition

Venous Thrombosis Pediatrics

Locations shown

Little Rock, Arkansas

Los Angeles, California

Los Angeles, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2015Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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